Trials designed to answer a range of questions, often incorporating multiple treatment arms are increasingly being considered in all phases of clinical research in both the pharmaceutical industry and public sector trials. A variety of terms including platform, umbrella and basket designs have been used to describe particular versions of this general framework. During this webinar a regulatory speaker will consider what is meant by the different terms and potential regulatory hurdles, while speakers from industry and the public sector will share their practical experiences of these types of trials.

Mahesh Parmar, MRC Clinical Trials Unit at UCL

Abstract

Testing many treatments within a single protocol over 10 years at the MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols

There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone. Ultimately, we often find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this presentation, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.

Upcoming Events

In 2020 we celebrate the bicentenary of Florence Nightingale’s birth and the need for statistical and data skills to improve health show no signs of abating. What lessons can we draw from Florence Nightingale to shape the future of statistics?

PSI Conference Webinar: Career Young Statistician Session

9 June, 2020, 10 AM-11 30 AM

PSI presents 4 very different talks from 4 statisticians still lucky enough to be deemed young in their careers. Jack Keeler will speak on enrichment designs with survival data; Ruth Owen on methods to evaluate the benefit-risk trade-off in individual patients; Ines Reis will give a young statistician’s guide to regulatory statistics and Georgios Nikoladis will talk about Borrowing strength from indirect evidence in HTA. A session not to be missed!

Our Impact and the Future Focus of PSI - 2020 PSI AGM

9 June, 2020, 1 PM-2 PM

Join us between Conference webinars to also hear about the key achievements from 2019, the impacts and adaptations stemming from COVID-19, and what there is to look forward to with PSI, through 2020 and beyond.

PSI Conference Webinar: In memory of Sally Hollis (former SIG Chair) - 'Data as an Asset, the re-use of data'.

9 June, 2020, 2 30 PM-4 PM

On behalf of the data transparency SIG, 3 speakers give their input on why we must now regard our data as an asset due to data transparency, the essential principles that statisticians need to be aware of regarding clinical data and patient privacy, how data can be re-used responsibly and the work of the Global Digital health unit, which uses real world data to drive precision medicine across the UK healthcare economy.

Christen Gray, Kirsty Hicks and Elizabeth Williamson each speak on their work related to real world data. Topics include Comparing the impact of unmeasured confounding due to selection bias in external comparator studies using RWD, Advanced Analytics of Digital Data: A focus on sensor data, and how we can use RWD to emulate trials.

PSI Conference Webinar: Retire Statistical Significance (!) (?) - How do we know what we know?

10 June, 2020, 2 30 PM-4 PM

Inferring what is likely to be true based statistical analysis of data is a very difficult task and certainly not as easy as computing a p-value for declaring H0 to be true or false based on an arbitrary cut-off value. This session will include the leaders from the two most prominent statistical societies in the world – The RSS (Deborah Ashby) and the ASA (Ron Wasserstein) – and moderated by Stephen Ruberg. Listen to their perspectives and sharpen your statistical thinking.

PSI Conference Webinar: PSI/RSS Prize Winners Session

11 June, 2020, 10 AM-11 AM

Listen in to two talks from the 2019 PSI/RSS Prize Winners, Mike Smith and Jacquie Christie. Mike will speak on his thoughts on innovation. What is innovation? How do I innovate? Is it a skill that I can learn or improve on? Jacquie will talk about quantative decision making for clinical development in the work she and Graeme Archer produced which was deemed to be ‘at the cutting edge of revolutionising data driven decision making within the industry’.

PSI Conference Webinar: Impact of COVID-19 to estimands.

11 June, 2020, 2 30 PM-4 PM

This webinar will focus on how the estimand framework can help us to pose and answer clinically relevant questions in the light of the COVID-19 pandemic. The case studies presented will illustrate how pre-specified estimands are impacted by the COVID-19 pandemic, and how methods for estimation including sensitivity analyses may need to be reconsidered to address missing data issues. This session brings together colleagues from the EFPIA/EFSPI estimand implementation working group and the Estimands in Oncology ESIG.

Introduction To Industry Training Course 2020

1 October, 2020

The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.

A PSI Training Course - R for SAS Users

20 October, 2020 at 9 30 AM-21 October, 2020 at 4 45 PM

This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R.
An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…

PSI Toxicology SIG Workshop

24 November, 2020 at 9 30 AM-25 November, 2020 at 4 45 PM

PSI Toxicology SIG workshop – 24th and 25th November 2020
The Toxicology SIG provides a forum for statisticians working in regulatory/investigative toxicology, as well as most other pre-clinical areas, to discuss issues and interact with one another.
This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.
The afternoon of Day 1 will include a 4.5 hour Bayesian training course focused towards applications in toxicology/pre-clinical, provided by Prof. Dr. Katja Ickstadt and is included in the workshop fee.
The cost will be £270 including VAT per delegate, inclusive of food and one night’s accommodation (and the training course). The workshop is being held at the Crowne Plaza Hotel, Heathrow.
The agenda and topics that will be discussed are yet to be finalised, but please get in touch with gareth.thomas@covance.com if you have suggestions. Full details will be circulated in the coming weeks.

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